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CERTIFICATE OF ANALYSIS
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Name |
Articaine Hcl |
Date of produce |
2023/06/03 |
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|
Batch No. |
23020603 |
Date test |
2023/06/08 |
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|
Expiry date |
2025/06/02 |
Inspection basis |
EP8 |
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|
ITEMS |
QUALITY STANDARDS |
RESULTS |
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|
Description |
A white or almost white crystalline power |
A white,crystalline power |
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|
Solubility |
Freely soluble in water and in alcohol |
Complies |
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|
Identification |
Complies |
Complies
|
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|
PH |
4.2～5.2 |
4.58 |
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|
Appearance of solution |
≤BY6 |
Complies |
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|
Appearance of solution |
Solution should be clear |
Complies |
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|
Related Substances |
Impurity A ≤0.2% Any other impurity ≤0.1% Total of other impurities ≤0.5% |
Not detected 0.05% 0.17% |
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|
Heavy metals |
≤5ppm |
＜5ppm |
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Loss on drying |
＜0.5% |
0.34% |
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Resiue on ignition |
≤0.1% |
0.04% |
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|
Organic residues |
acetone≤0.5% |
Not detected |
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Methanol≤0.3% |
Not detected |
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|
Ethyl acetate≤0.5% |
Not detected |
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|
Dichloromethane≤0.06% |
Not detected |
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Ethanol≤0.5% |
Not detected |
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|
Dimethyl sulfoxide≤0.5% |
Not detected |
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|
Assay(*) |
98.5～101.0% |
100.68% |
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|
Conclusion |
The Sample Complies With Specification of EP8 |
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